Understanding and responding to

Transcription

Understanding and Responding
to Pharmaceutical Promotion
A Practical Guide
First edition
Working Draft for Pilot Field Testing
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World Health Organization/Health Action International
Collaborative Project
Understanding and Responding
to Pharmaceutical Promotion
A Practical Guide
First edition
XX
X XX X
Working Draft for Pilot Field Testing
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X
X
XX
XX X
World Health Organization/Health Action International
Collaborative Project
This manual is dedicated
to the memory of
Lisa Waller-Hayes
Contents
Preface................................................................................................................... 3
Acknowledgements............................................................................................... 5
Abbreviations and acronyms.................................................................................8
1. Promotion of medicines and patient health ..................................................9
Barbara Mintzes
2. Techniques that influence the use of medicines ..........................................25
Peter R Mansfield
3. Analysing pharmaceutical advertisements in medical journals ...............41
Joel Lexchin
4. Pharmaceutical sales representatives ..........................................................61
Andy Gray, Jerome Hoffman and Peter R Mansfield
5. Promotion to consumers:
Responding to patient requests for advertised medicines .........................81
Barbara Mintzes, Les Toop and Dee Mangin
6. Learning how not to do the pharmaceutical industry tango:
Raising student awareness of ethical conflicts of interest........................105
Arthur Schafer and Nancy Olivieri
7. Regulation of pharmaceutical promotion:
Why does regulation matter?.....................................................................123
Lilia Ziganshina and Joel Lexchin
8. Using unbiased prescribing information...................................................145
Andy Gray, Bob Goodman, José M Terán Puente and Barbara Mintzes
9. Promotion, professional practice and patient trust..................................163
Dee Mangin
Preface | 3
Preface
Medicines can play a crucial role in the attainment or maintenance of health but it is vital that
they are used rationally. If a patient needs treatment, he or she must have access to the right
medication, in the right dosage and for the appropriate course of treatment. Health-care professionals, such as doctors and pharmacists, play a key role in ensuring that medicines are used
appropriately. As gatekeepers to care, they need to assess different treatment options, including
pharmacotherapy, and consider each for potential benefit and harm.
In 1994, the World Health Organization (WHO) published the Guide to Good Prescribing. This
publication was developed and field tested extensively before its release. After publication, it
was translated into multiple languages and was widely used. This guide highlighted the need
for students to learn to focus in a very practical way on treatment goals when making prescribing
decisions, and to develop their own personal formulary for commonly treated conditions. The
report of the evaluation was published in The Lancet (1995).
However, in recent years, growing concern has focussed attention on the relationship between
health-care professionals and the pharmaceutical industry - particularly the industrys influence
on prescribing and dispensing decisions through a range of promotional tools, which can influence
treatment choices. This influence can lead to less than optimal medication choices, sometimes
to the detriment of patient health.
Despite the fundamental nature of these treatment decisions and the important role of pharmaceutical
promotion in shaping them, health-care professionals receive little or no instruction on how to
assess pharmaceutical promotion and how to understand its often subtle influence on their
behaviour. In 2005 a WHO/Health Action International (HAI) cross-sectional, international
survey of educational initiatives on pharmaceutical promotion found that whilst many medical
and pharmacy faculties included this topic in their curriculum, most spent less than one day on
the subject - with some schools devoting only one to two hours to the issue. The survey also
showed that even though educators recognise the need for instruction on pharmaceutical promotion
and sometimes do their best to incorporate it into their work, it is mostly limited. There is,
therefore, both an identified need and an expressed determination by educators to further develop
curricula in this area.
This new publication is modelled on and should be seen as a companion module to the Guide
to Good Prescribing. It will assist teachers and health-care professionals to teach medical and
pharmacy students about pharmaceutical promotion. Understanding and Responding to Pharma-
4 | Understanding and responding to pharmaceutical promotion - a practical guide
ceutical Promotion A Practical Guide has been produced as part of a collaborative HAI/WHO
project focusing on pharmaceutical promotion and its effect on the rational use of medicines
in many countries around the world. It has been made possible thanks to the expertise and
knowledge of numerous WHO and HAI staff members and a broad group of educators and
activists working with the HAI network on pharmaceutical promotion.
This draft manual is a first step in addressing the need for medical and pharmacy professionals
to reconsider their central role as a target for pharmaceutical marketing and to provide some
understanding of how this fits into the wider context of promotion. Its nine chapters explore a
spectrum of related topics that will help them be better prepared to face the promotional activity
to which they will be exposed and to analyse information about medicines in order to make
choices that will contribute to the health of patients.
We do not consider this to be the final product. We encourage feedback on the material included
in this book so that it can be improved and updated as it is vital that this publication reflects the
real needs of students and educators. The manual will be rigorously pilot tested and evaluated
at a number of sites during 2009-2010 using English and Spanish versions of the text. Afterwards,
it will be revised following close examination of feedback and evaluation data. In addition,
classroom experiences using this text and its exercises will be collected in order to revise the
material for wider use in the future. We hope that the manual provides material for thoughtprovoking discussions and we look forward to receiving your comments.
Hans Hogerzeil
Director
ESSENTIAL MEDICINES AND PHARMACEUTICAL POLICIES
WORLD HEALTH ORGANIZATION
Geneva
Tim Reed
Director
HEALTH ACTION INTERNATIONAL GLOBAL
Amsterdam
Acknowledgements | 5
Acknowledgements
Health Action International (HAI) and the World Health Organization (WHO) would like to
thank all of the project members who have contributed so much of their time and expertise to
ensure the successful introduction of this manual.
We would also like to express our gratitude to the WHO and the other donors that contribute
to HAIs Global Programme of Work (the Netherlands Ministry of Foreign Affairs, the Swedish
International Development Cooperation Agency and the Finnish International Development
Agency) for their generous support of this project.
Special thanks are due to the following people who played a vital role in developing the text
for this manual, reviewing material and providing oversight on the project.
Project management
Barbara Mintzes, PhD, HAI Global, Amsterdam, the Netherlands and Assistant Professor, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Canada
Richard Laing, Team Leader, Medicine Information and Evidence for Policy, Department of
Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland
Tim Reed, Marg Ewen, Lisa Hayes and Carole Piriou, HAI Global, Amsterdam, the Netherlands
Manual editors
Barbara Mintzes, Dee Mangin and Lisa Hayes
Contributing authors
Robert L Goodman, MD, Assistant Professor of Clinical Medicine, Albert Einstein College of
Medicine, Bronx, New York, US
Andy Gray, Department of Therapeutics and Medicines Management, Nelson R Mandela School
of Medicine, University of KwaZulu-Natal, South Africa
Jerome Hoffman, MA, MD, Professor of Medicine, UCLA School of Medicine, US
Joel Lexchin, MD, Professor, School of Health Policy and Management, York University,
Toronto, Canada
Dee Mangin, MB, ChB, DPH, Associate Professor and Director, Primary Care Research Unit,
Department of Public Health and General Practice, University of Otago, Christchurch, New Zealand
Peter R Mansfield, MD, OAM BMBS, General Practitioner; Director, Healthy Skepticism, Inc.;
Visiting Research Fellow, University of Adelaide, Australia
Barbara Mintzes, PhD, HAI Global, Amsterdam, the Netherlands; Assistant Professor, Department
of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Canada
and Michael Smith Health Research Foundation Scholar
Nancy F Olivieri, MD, FRCP(C), Professor, Pediatrics, Medicine and Public Health Sciences,
University of Toronto, Canada
Arthur Schafer, Professor and Director, Centre for Professional and Applied Ethics, University
of Manitoba, Canada
José M Terán Puente, MD; Professor of Pharmacology, School of Medicine, Pontificia Universidad
Católica del Ecuador; AIS-Ecuador Coordinator
Les Toop, MB, ChB, MD, FRNZCGP, Professor and Head, Department of Public Health and
General Practice, University of Otago, Christchurch, New Zealand
Lilia Ziganshina, MD, PhD, Doctor of Sciences, Professor, Kazan State Medical Academy,
Russia and HAI Global, Amsterdam, the Netherlands
Project advisory team
Robert L Goodman, US; Andy Gray, South Africa; Jerome Hoffman, US; Richard Laing, WHO,
Geneva; Joel Lexchin, Canada; Dee Mangin, New Zealand; Peter Mansfield, Australia; Barbara
Mintzes, Canada and HAI Global, the Netherlands; Nancy Olivieri, Canada; Tim Reed, HAI
Global, the Netherlands; Arthur Schafer, Canada; Sri Suryawati, Indonesia; José M Terán Puente,
Ecuador; Les Toop, New Zealand and Lilia Ziganshina, Russia and HAI Global, the Netherlands
Acknowledgements | 7
Translators
Russian: Veronica N Khaziakhmetova, MD, PhD, Associate Professor; Tatiana Abakumova,
MD, PhD, Assistant Professor; Irina Burashnikova, PhD student; Aleksandra Kuchaeva, MD,
PhD, Assistant Professor; Albina Titarenko, MD, PhD, Assistant Professor; Department of
Clinical Pharmacology, Kazan State Medical Academy, Russia.
Spanish: Lillian Levy, Bàrbara Sanchez and Miquel-Àngel Sánchez Férriz with support from
José J López, National University of Colombia (Chapter 8).
Editors
Spanish: Benoît Marchand, AIS-Nicaragua; Claudia Vacca, National University of Colombia/
IFARMA (AIS-Colombia); and Martin Cañás, GAPURMED, (AIS-Argentina)/Femeba
Russian: Lilia Ziganshina, MD, PhD, Doctor of Sciences, Professor, Kazan State Medical
Academy, Russia and HAI Global, Amsterdam, the Netherlands
Editorial and administrative support
Rose de Groot, HAI Europe
Kath Hurst, WHO, Geneva
Magenta Simmons (psychology literature searches, Chapter 2)
Abbreviations and Acronyms
ABPI
Association of the British Pharmaceutical Industry
ARR
Absolute Risk Reduction
CLASS
Celecoxib Long-Term Arthritis Study clinical trial
CME
Continuing Medical Education
DDMAC US Food and Drug Administration's Division of Drug Marketing,
Advertising and Communication
DTCA
Direct-to-Consumer Advertising
FDA
US Food and Drug Administration
HAI
Health Action International
IFPMA
International Federation of Pharmaceutical Manufacturers & Associations
INN
International Nonproprietary Name
KOL
Key Opinion Leaders
NNT
Number Needed to Treat
PhRMA
Pharmaceutical Research and Manufacturers of America
ROI
Return on Investment
RRR
Relative Risk Reduction
Rx&D
Canada's Research-based Pharmaceutical Companies
UK
United Kingdom
US
United States of America
VIGOR
Vioxx Gastrointestinal Outcomes Research clinical trial
WHO
World Health Organization
Chapter 1 - Promotion of medicines and patient health | 9
Chapter 1
Promotion of medicines
and patient health
Barbara Mintzes
Why discuss pharmaceutical promotion?
Medical and pharmacy students often begin to have contact with pharmaceutical industry
representatives early in their training. For example, a survey in Finland found that nearly half
of all medical students attended presentations by sales representatives at least twice a month
(Vainomaki et al., 2004). In the United States (US), third-year medical students on average
received one gift or attended a sponsored activity each week, and over nine out of ten had been
asked by faculty members to attend sponsored lunches (Sierles et al., 2005). Most students in
both surveys believed that their own prescribing was unlikely to be affected by pharmaceutical
promotion and many students accepted gifts although they disapproved of them in principle.
In India, final-year medical and pharmacy students were unaware of incentives offered by
pharmaceutical manufacturers to pharmacies to boost medicine sales. However, most had seen
prescription-only medicines being dispensed without a prescription (Kumar et al., 2006).
Links between pharmaceutical manufacturers and medicine and pharmacy are omnipresent but
students often receive very little education about the effects of these interactions or how to
manage them (Mintzes, 2005). This can create a hidden curriculum in which students subconsciously learn that promotional information, sponsored education and acceptance of gifts and
free samples are accepted norms of professional practice (Sierles, 2005).
This manual aims to bring this hidden curriculum into the open, to give you an opportunity to
think beforehand about how to manage interactions with industry representatives and to develop
skills that you can use throughout your professional life. It covers techniques used by the pharmaceutical industry to influence the use of medicines, advertisements, sales representatives, promotions aimed at the public, ethical conflicts, regulation and avoiding bias in information about
medicines. Each chapter is accompanied by practical exercises and illustrative examples. We
hope that you will find the manual a useful preparatory resource for your professional practice.
Aims of this chapter
This introductory chapter describes the extent and types of pharmaceutical promotion and
provides an overview of the research evidence on effects of promotion. By the end of the session
based on this chapter you should be able to:
· Document the scale of promotion in terms of industry spending;
· Describe the different types of pharmaceutical marketing;
· Describe evidence showing the effects of pharmaceutical marketing on professional practice.
Tension between health and commercial aims
Medicines are a core part of health-care services and their use has grown enormously during
the last century with the advent of effective antibiotics, anaesthetics, painkillers, antiretrovirals
and many other medicines. They can cure diseases, relieve symptoms and prevent future illhealth. Appropriate medicine use means providing the right medicine at the right dose, when
it is needed, and avoiding medicines that are unnecessary or are unlikely to result in health
benefits. It means choosing the treatment with the best effectiveness and safety profile among
available alternatives and the least costly of equivalent treatments.
These decisions require knowledge of a persons health condition, life situation and preferences
and access to unbiased, comparative information on the benefits and harmful effects of the range
of available treatment options.
The international pharmaceutical industry plays an important role in the development, production
and distribution of medicines. In many countries, it has also become the major funder of continuing medical education (CME) and research. However, a tension exists between pressures to
expand product sales within a competitive market and patient care. The World Health Organization
(WHO) described "an inherent conflict of interest between the legitimate business goals of
manufacturers and the social, medical and economic needs of providers and the public to select
and use drugs in the most rational way." (WHO Europe, 1993).
The global medicines market
In 2007, global pharmaceutical sales amounted to US$712 billion (IMS, 2008). The top product,
in terms of sales, was the cholesterol-lowering medicine Lipitor (atorvastastin), which had sales
of US$13.6 billion (Scrip, 2007). This is more than the gross national income of over half of
the worlds countries (World Bank, 2008). The effects of promotion in fuelling sales of specific
brands should not be underestimated. For example, sales of Lipitor (atorvastatin) were much
higher than sales of simvastatin and pravastatin, two medicines in the same class that have
similar effectiveness and are less costly (Prescrire, 2006).
Newer medicines are not necessarily better
To get a new medicine to market, a company must provide evidence of effectiveness, safety and
manufacturing quality. Effectiveness and safety evidence includes laboratory, animal and clinical
studies. The largest are phase III, randomised, controlled trials in patients with the disease the
medicine aims to treat. Most of these studies compare a new medicine to a placebo. Many people
are unaware that manufacturers do not need to show that a new medicine is better than existing
treatments. The new medicine must have the claimed beneficial effect to an acceptable extent
compared with placebo and be acceptably safe. To test the medicines efficacy, the manufacturer
carries out the randomised, controlled trials involving patients with the condition to be treated
by the new medicine. These are usually relatively short-term studies and may last a few weeks
to a few months, even when the treatment is for a chronic disease. For some serious diseases
for which placebo treatment would be unethical, a new medicine is compared with existing
treatments. However, these studies aim to show that a new medicine is as effective as alternatives,
or no less effective; it does not need to be better.
When a new medicine comes to market, it has only been tested on highly selected groups of
clinical trial participants. For example, the elderly and those with co-morbid, chronic conditions
are usually excluded. Too few people have been exposed to assess rare harmful effects, generally
3,000 to 5,000 people. Because of this inevitably incomplete safety assessment, there is a rationale
from a public health perspective and an individual patient care perspective for a slow, cautious
approach to the introduction of new medicines.
Table 1 presents an overview of ratings by an independent drug bulletin, La revue Prescrire,
of new medicines and newly approved indications for medicines in France over a 24-year period.
Around 10% were judged to have advantages over existing therapies. As this table further shows,
when it comes to medicines, newer is not necessarily better. As already mentioned, a new drug
does not need to show any improvements over existing treatments to be approved for marketing.
However, companies need to recoup investments in drug development as well as make a profit
for shareholders and so new medicines tend to be heavily promoted, whether or not they offer
treatment advantages.
Table 1: New medicines and indications in France 1981-2004
Number of
new medicines
or indications (%)
Rating
Explanation
Bravo!
Major therapeutic advance
7 (0.2)
A real advance
Important therapeutic advance,
with certain limitations
77 (3)
Offers an advantage
Some advantages, but not enough
to fundamentally affect clinical practice
223 (7)
Subtotal: Advantages over existing treatments
307 (10)
Possibly helpful
Minimal advantages over existing treatments
467 (15)
Nothing new
No additional value
Subtotal: Minimal to no advantage
2,109 (68)
2,576 (83)
Judgment reserved
Inadequately documented safety and/or efficacy
126 (4)
Not acceptable
Real or potential disadvantages
over existing therapies
87 (3)
Subtotal: To be avoided - inadequately tested or worse clinical profile
Total
213 (7)
3,096 (100)
(Source: La revue Prescrire, 2005)
Widespread influence
Links between the health professions and the pharmaceutical industry have grown enormously
in the late 20th and early 21st centuries, leading to a call from physician educators for strong
firewalls to protect the independence of academic medical centres (Brennan, 2006). In a large
US survey (Campbell, 2007), over 90% of physicians reported some type of relationship with
the pharmaceutical industry:
·
·
·
·
8 out of 10 received gifts, usually free food at their workplace;
8 out of 10 received free medicine samples;
4 out of 10 had their expenses paid to attend meetings and conferences;
3 out of 10 were paid consultants, on a company speakers bureau or advisory board.
Surveys in wealthy, industrialised countries have found that physicians see an average of one
sales representative a week (Wazana, 2000). In Turkey, however, more than half of urban
physicians in the third largest city, Izmir, saw at least one sales representative each day and onethird spent more than 30 minutes a day with sales representatives (Guldal, 2000). Although twothirds of the surveyed physicians believed that sales representatives did not influence their
prescribing, most said that they used advertisements and brochures as an information source.
There have been relatively few studies of relationships between pharmacists and the pharmaceutical
industry. One national US survey examined attitudes to the pharmaceutical industry and to
pharmaceutical promotion (Farthing-Papineau, 2005). Two-thirds of this random sample of
1,640 pharmacists in hospital and community practice reported that sales representatives provide
gifts to pharmacists that have no relation to patient care.
Spending on pharmaceutical promotion
Figure 1 provides a breakdown of promotional spending in the US in 2004, where information
on spending is publicly available. Advertising in professional journals is a small part of spending
only 2%. In terms of direct company expenses, the largest promotional category is detailing
to doctors. Detailing is a North American term for one-to-one sales representatives visits.
Sales representatives also distribute samples during sales visits so these two types of promotion
are strongly linked.
The US is unusual among industrialised countries in allowing direct-to-consumer advertising
(DTCA) of prescription medicines on television, magazines and billboards. In 2004, spending
on DTCA reached US$4 billion ( Gagnon, Lexchin, 2008).
Figure 1: US promotional spending on prescription medicines, 2004
US$57.5 billion in promotional spending
in the US in 2004
Unmonitored
promotion
Samples
E-promotion,
mailings, trials
Journal ads
Meetings
DTCA
(Source: Gagnon, Lexchin, 2008)
Sales
representatives
Figure 1 is an analysis of promotional spending in the US that includes the most accurate
estimates from two pharmaceutical market research firms, IMS Health and CAM. The figure
is notable for the approximately 30% of spending on unmonitored promotion. What types of
activities are covered? In part, this includes a range of non-traditional promotional activities
described in the pharmaceutical marketing literature and in court cases about pharmaceutical
promotion (Steinman, 2006).
Box 1: Non-traditional forms of marketing
# Industry-sponsored continuing medical and pharmacy education
# Funding of key physician opinion leaders
# Ghost-writing of journal articles
# Funding of diagnostic and treatment guideline development
# Public relations campaigns including unbranded disease-oriented advertising
# Funding of patient groups and medical societies
# Market seeding research (Phase IV studies without clear scientific objectives)
# Internet advertising
# Journal supplements and free journals
# Pharmacy discounts linked to sales volume*
*A common form of promotion in many developing and middle-income countries, where prescription-only
status of medicines is not enforced.
Key opinion leaders
Figure 2 shows the number of pharmaceutical-industry-sponsored meetings and presentations
held in the US in 1999 and five years later, in 2004, showing a quadrupling of the frequency
of these sorts of events.
Figure 2: Number of sponsored meetings and talks in the US, 1999 and 2004
237,000
250,000
200,000
150,000
1999
2004
100,000
66,000
50,000
0
Sponsored meetings and talks
(Source: Caplovitz, 2006)
Presentations by a physician who is sponsored by a company may not look like direct advertising
to the audience and this may increase their effectiveness. Documents from rofecoxib (Vioxx)s
manufacturer Merck, cited in the Wall Street Journal, stated that physicians attending lectures
by a sponsored physician wrote, on average, an additional US$624 worth of prescriptions during
the following year compared to doctors who had not attended such presentations (Hensley,
2005). In contrast, meetings with sales representatives generated an increase of US$166. These
internal documents suggest that sponsored talks were an integral part of Mercks marketing
strategy (Caplovitz, 2006).
Pharmaceutical marketers refer to paid health professional spokespeople as key opinion leaders.
"An awful lot of the doctors in the audience are naive about the fact that these are really sales
talks," comments Jerry Avorn of Harvard Medical School, US, (Hensley, 2005). In one US state,
Minnesota, over one year more than 20% of physicians received payments from pharmaceutical
companies, and over 100 physicians received more than US$100,000 (Spurgeon, 2007).
Continuing medical education
Between 1998 and 2003, financing of CME by pharmaceutical companies nearly tripled in the
US, from US$302 to $971 million, and most CME is funded by the pharmaceutical industry
(Steinbrook, 2005). The standards governing commercial support do not prevent sponsors from
discussing content with academic providers and suggesting topics or speakers.
Free samples
Many physicians view free samples positively and stock them to provide to patients who would
otherwise have to pay for medicines and cannot afford them. A key reason that many physicians
see sales representatives is to obtain free samples.
One study compared prescribing decisions before and after a family practice outpatient clinic
brought in a policy prohibiting free samples (Boltri, 2002). Figure 3 compares initial prescriptions
of medicines for high blood pressure during the two time periods. Current treatment guidelines
had identified diuretics and beta blockers as first-line treatments for uncomplicated hypertension
(National Institutes of Health, 1997). These inexpensive, off-patent medicines were not being
actively promoted. When samples were available, patients received second-line treatments more
often as initial therapy. These should generally be reserved for patients unable to tolerate firstline treatments or for whom first-line medicines are ineffective. The conclusion of this study
was that banning samples improved the quality of care provided to patients.
Figure 3: Effect of free samples of medicines on prescribing decisions
Antihypertensive prescribing
100%
90%
80%
70%
62%
61%
60%
50%
39%
38%
40%
Second-line drug
First-line drug
30%
20%
10%
0%
Samples Available
Samples Unavailable
(Source: Boltri, 2002)
Sponsored clinical practice guidelines
The sponsorship of authors of treatment guidelines raises concerns that the advice provided may
be biased in favour of sponsors products. A study of over 200 guidelines from a variety of
countries included in a US National Guideline Clearinghouse found that around one-third of
authors had financial links to companies producing the treatments they were evaluating, and
nearly three-quarters of guideline panels included authors with conflicts of interest (Taylor,
2005). It is not only a problem of a specific product being favoured. Treatment norms can also
be affected and a shift in criteria can mean that millions more people can be defined as needing
therapy. For example, when European Society of Cardiology guidelines were applied to a county
in Norway, three-quarters of the population was defined as being at increased risk and potentially
needing treatment (Heath, 2006).
Ghost-writing
Ghost-writing of journal articles refers to a practice in which research publications with academic
authors are in fact written by pharmaceutical company employees or medical communication
companies working for pharmaceutical companies.
David Healy, a psychiatrist at the University of Wales, describes having been invited to speak
at a sponsored medical conference and being presented with a ghost-written paper for inclusion
in an associated journal supplement. He refused the paper and wrote his own, only to find the
ghost-written paper published with a different academic authors name on it (Healy, 1999). He
also describes more systematic use of ghost-writing to market sertraline (Zoloft), which surfaced
in a document prepared by the medical information company Current Medical Directions Incorporated (CMD) that became public during a US court case (Healy, 2003). CMD listed draft articles
with authors to be determined and 55 subsequently published articles were linked to CMDs
list. These included the results of 25 clinical trials, all favourable to sertraline. On average each
had 6.6 listed authors; some academic authors appeared more than once. A ghost-written paper
may also condemn a competitors products. A US physician described an article she was asked
to sign that did not mention the sponsors medicine, but raised safety concerns about a competing
treatment (Fugh-Berman, 2005).
In response to the problem of ghost-writing, major medical journals have tightened up their
guidelines for authorship (see: http://jama.ama-assn.org/cgi/content/full/284/1/89). However,
many journals publish company-sponsored supplements, usually consisting of reports of sponsored
symposia and presented papers. The company pays for these extra journal issues and has a large
degree of editorial control over contents. Bero and colleagues (1992) analysed over 600 symposia
reports appearing in 58 major medical journals over 23 years. Those with a single pharmaceutical
company sponsor were more likely to have misleading titles and use brand names rather than
generic names or the International Nonproprietary Names (INN) and were less likely to be peerreviewed than articles in regular issues of the journal.
Activities aimed at increasing sales
Several recent US court cases have led to the release of internal documents that highlight the
variety of activities used to increase sales of medicines. Gabapentin (Neurontin) was approved
in the US as a secondary treatment for epilepsy. As Figure 4 shows, soon most prescriptions
were for unapproved or off-label use. Promotion of unapproved uses of a medicine is illegal
both in the US, where this court case occurred, and elsewhere. The problem with promotion of
medicines for unapproved uses is that the company has not provided systematic evidence of
efficacy or safety to the national regulatory agency for these uses. In many cases, the medicine
has not been adequately tested and potential benefits may not outweigh potential harm. This
was the case for many of the uses for which gabapentin was promoted (Steinman, 2006). Details
about promotional activities that encouraged off-label use surfaced in this court case: Gabapentin
[Neurontin] was promoted by using education and research, activities not typically recognized
as promotional, independent continuing medical education, peer-to-peer selling by physician
speakers, and publications (Steinman, 2006).
Figure 4: Gabapentin (Neurontin) use for unapproved indications
Prescriptions (in Thousands) per Quarter, n
1000
900
800
700
600
Psychiatric disorders
Migraine
Pain
Other
Epilepsy*
500
400
300
200
100
0
1994
1995
1996
1997
1998
Year by Quarter
* The only use for which gabapentin was approved over this period.
(Source: Steinman, MA et al., 2006)
1999
2000
From promotion to medicine use
The prescribing pattern for gabapentin (Neurontin) illustrated in Figure 4 is consistent with the
promotional activities described during the Neurontin court case (Steinman, 2006). However,
in surveys, physicians typically report that promotion has little effect on their prescribing
decisions. For example, a study of internal medicine residents found that only 1% believed that
promotion had a strong effect on their prescribing decisions and most felt it had no effect
(Steinman, 2001).
Evidence shows promotion affects health-care provision
If promotion of medicines did not affect treatment decisions, would pharmaceutical companies
pour billions of dollars into marketing targeting professionals each year? Given companies need
to show a healthy profit to their shareholders, this seems unlikely. Market research companies
calculated the average return, in increased sales, per dollar invested in pharmaceutical promotion
in 2004 at US$8.34 (Arnold, 2005). Fortune 500 ratings also consistently rank the pharmaceutical
industry as having among the highest returns on investment of any industry: in 2006 it ranked
second, after the oil industry, with a 19.6% rate of profits as a percentage of total revenues
(Fortune, 2007). The research evidence confirms the fact that promotion does affect professional
practice.
Inaccurate beliefs about promotions influence
Despite this profitability and the numerous examples of industry influence on health care, many
health professionals underestimate the effects of pharmaceutical promotion on their beliefs and
professional practice. The first study to examine the contrast between beliefs about influence,
and a measure of that influence, surveyed a sample of Boston area physicians about their beliefs
in two commercial myths that were not supported by scientific evidence (Avorn, 1982). These
were beliefs that: (a) propoxyphene, an analgesic with a poor safety profile, was more effective
than aspirin; and (b) poor blood flow was a major cause of senile dementia. The latter supported
the use of vasodilators to treat dementia, although they had not been shown to be effective.
Although most of the surveyed physicians stated that they relied on scientific information sources,
they also believed these non-scientific commercial myths. More recent studies of effects of
free samples and sponsored symposia on prescribing behaviour have similarly found an effect
on prescribing despite health professionals beliefs that they were unaffected (Adair, 2005;
Orlowski, 1992).
Negative effects on prescribing
In 2005, Norris et al. conducted an extensive review of 2,700 journal articles in the WHO and
Health Action International (HAI) database on pharmaceutical promotion (www.drugpromo.info).
They found that physicians frequently use promotion as a source of information about new drugs
and, agreed with Avorn et al.s findings, that promotion influences attitudes more than physicians
realize (Norris et al., 2005). Much less research was available on effects on pharmacists or other
health professionals attitudes.
Physicians who report that they rely to a greater extent on promotion prescribe less appropriately,
have higher prescribing volumes and adopt new medicines more quickly (Norris et al., 2005).
Industry sponsorship can affect the content of CME and industry-funded research and is more
likely to show results that are favourable to the sponsor. Additionally, patients with exposure
to DTCA of prescription medicines are also more likely to request advertised medicines. Norris
et al. highlighted the need for more research on the public health impacts of pharmaceutical
promotion.
A systematic review published in the Journal of the American Medical Association identified
29 studies published from 1994-1999 that examined the effects of interactions between physicians
and the pharmaceutical industry and effects on knowledge, attitudes and behaviour (Wazana,
2000). These were comparative studies pre- and post-exposure to promotion, comparative cohort
studies, case-control studies and cross-sectional surveys. Here are the key findings:
# Most surveyed physicians denied that gifts could influence their practice;
# The more gifts physicians received, the less likely they were to believe their prescribing
would be affected;
# The more frequent the contact with sales representatives, the greater the likelihood that
physicians would request addition of sponsors products to hospital formularies;
# Payment for conference travel, industry-sponsored meals, research funding and honoraria
also increased the likelihood of requests for formulary additions versus other physicians who
had not received such payments;
# More exposure to talks by sales representatives was associated with less ability to recognise
inaccurate claims about medicines;
# CME funding increased the likelihood of prescribing sponsors products;
# More frequent contact with sales representatives was associated with higher prescribing costs,
more rapid prescriptions of new medicines and less prescribing of generics.
Little regulation
As described, promotion affects prescribing and medicine use, with likely negative effects on
both costs and quality of care. Many countries have laws governing pharmaceutical promotion.
Manufacturers are generally prohibited from providing deceptive or misleading information or
promoting medicines for unapproved uses. These laws reflect a recognition that medicines can
lead to harm as well as benefit; and therefore need to be provided and used with care. Additionally,
an international set of standards exist for regulation of promotion, the WHO Ethical Criteria
for Medicinal Drug Promotion, with the aim to support and encourage the improvement of
health care through the rational use of medicinal drugs. (WHO, 1988).
In conclusion: far from a trivial issue
In parallel to the lack of priority given to regulation, pharmaceutical promotion has received relatively little attention in medical and pharmacy education (Mintzes, 2005). This lack of attention
stands in stark contrast to the billions of dollars spent each year on pharmaceutical promotion.
Health professionals often incorrectly believe that they are not being influenced by promotion
and may have little training on how to distinguish ethical from unethical promotional practices.
Unethical promotion can affect patient care negatively. Shahram Ahari, ex-sales representative
for Eli Lillys antipsychotic medicine olanzapine (Zyprexa), imagines the management decisions
that led to the instructions he received to downplay risk information: Decisions like these are
simply a cost-benefit analysis somewhere up there. This diabetes, this weight gain, sure it exists,
but if we start talking about it now well lose billions of dollars. (Ahari, 2007).
Interactions between health professionals and the pharmaceutical industry often begin early in
training. Discussing these interactions can help to distinguish ethical from unethical relationships
and biased from accurate information. Training in therapeutics is an important part of professional
education. It is also important to understand the context in which these therapeutic decisions
about medicine use are made. The aims of this manual are to raise awareness among pharmacy
and medical students of this broader context surrounding medicine use; to provide background
information about the types and extent of promotion and the research evidence on its effects;
and to assist in the development of practical skills to guide interactions with the pharmaceutical
industry in professional practice. The goal, ultimately, is improved patient care.
References
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Chapter 2 - Techniques that influence the use of medicines | 25
Chapter 2
Techniques that influence
the use of medicines
Peter R Mansfield
The pharmaceutical industrys marketing activities are successful in achieving sales because
they are able to influence the decision-making process of health professionals and patients, and
therefore the prescribing and dispensing of medicines. Health professionals often have a limited
awareness of the influence of promotion, and promotion is more effective than many realize.
It is common for health professionals to believe that promotion doesnt affect me. As one family physician put it, Just because I have a pen with the name of a drug on it, doesnt mean Im
going to prescribe it. (Prosser et al., 2003). Often, however, professionals have less confidence
in the abilities of their colleagues to resist misleading persuasion (Zipkin and Steinman, 2005).
Aim of this chapter
The aim of this chapter is to help you understand the techniques that pharmaceutical companies
use to promote the use of medicines. It is important that you are aware of the impact these
techniques have and your own vulnerability to them in order to best care for your patients. By
the end of the session based on this chapter you should be able to:
# Explain why health professionals are vulnerable to influence techniques;
# Describe some of the common techniques used to influence the decision-making of health
professionals;
# Discuss strategies for responding to pharmaceutical promotion.
Vulnerability to marketing influences
Anyone can be influenced by sophisticated marketing techniques, and all too often we are
unaware of this influence. Health professionals are no different from other human beings in this
respect. However, a major difference between promotion aimed at health professionals and many
other forms of marketing is that the aim is to affect recommendations made for patients, not
purchases made by professionals themselves.
Box 1: A selling success
Promotion versus scientific evidence
The US$3.8 billion in sales for esomeprazole (Nexium) in 2003 (a medicine used to treat
heartburn and other stomach acid problems) is an example of the ongoing importance
of commercial influences on prescribing (Anon, 2003). Without a strong commercial myth
of superior effectiveness informing prescribing decisions, this sales volume would be
highly unlikely, as the same treatment effect can be achieved much less expensively with
esomeprazoles parent medicine, generic omeprazole, when used at equipotent (equivalent)
doses (Therapeutics Initiative, 2002).
Health professionals know they have a fiduciary responsibility to put patients interests and care
first, before their own personal gain. Thus pharmaceutical marketers must ensure that their
activities appear to contribute to patient care, whether the medicine they are promoting is the
best available treatment for a professionals patients or not. A number of marketing techniques
assist in this process, as described throughout this manual. Two key factors also contribute to
health professionals vulnerability to marketing influences: belief in their own invulnerability
and the use of decision-making shortcuts.
Belief in invulnerability
Many health professionals believe that they are not personally influenced by pharmaceutical
promotion, but that their colleagues are affected (Zipkin and Steinman, 2005). For example, a
survey of internal medicine residents asked them how much influence pharmaceutical sales
representatives had on their prescribing. As Figure 1 shows, there was a large difference in their
beliefs about influences on their own prescribing and that of colleagues (Steinman et al., 2001).
Figure 1: Survey of hospital doctors about sales representatives' influence
How much influence do
sales representatives have
on your prescribing?
How much influence do
sales representatives have
on other physicians prescribing?
A lot
1%
A little
38%
None
16%
None
61%
A lot
51%
A little
33%
(Source: Steinman, 2001)
Psychologists have found that it is normal for people to believe that only other people are
vulnerable to being misled by promotional techniques. This is called the illusion of unique
invulnerability (Sagarin et al., 2002).
That such beliefs are illusionary is reinforced by the research evidence: Increased promotion
is associated with increased medicine sales, promotion influences prescribing more than doctors
realise and doctors rarely acknowledge that promotion has influenced their prescribing. Doctors
who report relying more on promotion prescribe less appropriately, prescribe more often and
adopt new drugs more quickly. (Norris et al., 2005).
Decision-making shortcuts
Health professionals are continually faced with decisions about whether a treatment is needed
and which of a range of available treatments to recommend. Because of the need to constantly
make pragmatic decisions to try to resolve patients health problems quickly and efficiently,
health professionals often rely on decision-making shortcuts. These can include, for example,
trust in experts recommendations, use of a medicine because many colleagues are prescribing
it, or choice of the first treatment that comes to mind or is available as a sample, rather than
researching all available alternatives for treating a particular condition.
These shortcuts create additional vulnerabilities where promotion may influence physicians.
Experienced health professionals often use shortcuts with little awareness of doing so, similarly
to the way experienced drivers change gears with little conscious effort (Robinson, 2000).
Decision-making shortcuts and the techniques that influence them have been studied by logicians,
psychologists, advertising agencies and others some were even described by Aristotle around
350 BC. (For more on this, see Fischer, 1970; Chaiken, 1999 and Zaltman, 2003.)
The aim of promotional activities
In a crowded marketplace with many available treatments, pharmaceutical companies have a
commercial imperative to persuade professionals that their product is the best choice in order
to maximise profits. This is done through a variety of influence techniques that form the core
of successful marketing. The aim is to persuade professionals who are initially unaware of a
medicines existence to move through the following series of stages:
Unawareness
Awareness
Interest
Evaluation
Trial
Use
Repeat use
(Lidstone and Collier,1987; Prochaska and DiClemente,1983)
Pharmaceutical companies use a mix of delivery methods including advertisements, pharmaceutical
sales representatives, sponsorship and public relations. Messages delivered with these different
methods reinforce each other. Promotional techniques can influence prescribers at different
stages of this process. Companies often use advertising as a cost-effective way to create awareness
of a product. Pharmaceutical sales representatives can build from this and focus on moving
through subsequent stages. Use of expert or peer key opinion leaders to discuss a new product
can also be effective in shifting health professionals from unawareness to awareness and ideally
(for the marketer) interest in a product.
Evaluation of a new medicine is based on an impartial examination of the scientific evidence.
However, even when evidence is available, few busy clinicians have the time required to perform
systematic reviews or to critically appraise research reports. Additionally, the available evidence
may be flawed due to poor research design, incomplete reporting, its funding source and publication bias or it may not be relevant to patient care decisions a clinician is facing. Sometimes
an independent research group will have carried out a systematic evaluation of treatment options,
but these evaluations may not be readily available or familiar to professionals. (See Chapter 8
for information sources.) Sponsored consensus statements and guidelines provide professionals
with an existing evaluation that can be positively biased in favour of using the sponsors product.
For example, treatment guidelines for patients with kidney disease that were sponsored by
Amgen, the manufacturer of epoetin alfa (Epogen), recommended high-target haemoglobin
levels (Coyne, 2007). This recommendation was likely to have led to more widespread prescribing
of epoetin alfa in patients with kidney disease (Coyne, 2007).
Both marketing trials and provision of free samples are means of moving physicians past this
evaluation stage to the stages of trial and use, in other words, to get them to try out a product
on their patients, with the aim of stimulating broader use and repeat use. These are forms of
market seeding. Marketing trials are studies that have a commercial rather than a real scientific
objective, in which doctors are generally asked to prescribe a medicine to a certain number of
patients and record outcomes. Usually there is no comparison group or any precise research
hypothesis being tested. Prescribers are usually paid to be part of these marketing trials.
Misleading information
In this chapter, we refer to a variety of techniques that aim to influence the use of medicines
as influence techniques. Influence techniques can lead to good or harm. These are techniques
that pharmaceutical companies employ in promotional activities. They are harmful when linked
to misleading information. Systematic evaluations of advertisements and other promotional
information sources have found a consistent trend towards exaggeration of benefits and downplaying of harmful effects (Norris, 2005). This is similar to what happens in marketing of other
products, such as the whiter than white claims for laundry soap. However, exaggerating a
medicines benefits can lead to negative effects on patient health. There are three main ways
that information can be misleading:
# Inclusion of flawed information (e.g. inaccurate, exaggerated, ambiguous or oversimplified);
# Omission of relevant information;
# Distraction with irrelevant information.
Omissions and distractions can as effectively misrepresent the existing evidence as inaccuracies,
but are often harder to spot. For example, systematic analyses of pharmaceutical advertisements
consistently find that inadequate information is provided about the known harmful effects of
the promoted medicine (see Chapter 3).
Sales representatives
Table 1 describes some examples of common influence techniques used by sales representatives, as
recorded in a qualitative study of sales representatives presentations in Australia (Roughead, 1998).
Table 1: Common influence techniques used by sales representatives
Unconscious
influences on a
persons judgement
Use of this unconscious
influence for
marketing purposes
Experts know best
Professor Z recommends medicine B.
Peers know best
Medicine B is the most frequently prescribed medicine for indication X.
People we like
can be trusted
Use of attractive, friendly representatives.
We should help
others who have
helped us
Use of gifts, including free samples of expensive new medicines.
People should be
consistent with
their past statements
Sales representative: Do you treat many people with indication X?
Doctor: Yes.
Sales representative: So you need to know about the treatments
for indication X?
Doctor: Yes.
Sales representative: Would you like me to tell you about our
medicine B for indication X?
Doctor: Yes.
Note: this is an example of the commitment consistency technique
- getting the physician to agree to successive statements that are
consistent with one another, ending up at the conclusion the marketer
wants, although if the final question had been asked first, the physician
would probably not have agreed. Often the final statement is, So
doctor, will you try medicine B for your patients with indication X?
(Adapted from Cialdini, 2000; Roughead, 1998)
Box 2: A sales representative describes how to boost sales
Michael Oldani worked for nine years as a sales representative for a multinational
pharmaceutical company. He describes a number of influence techniques he and his
colleagues learned to use. For example, when physicians objected to a promotional claim,
he would reply empathetically about how pleased he was they had brought up this point
before countering the objection, then close the loop using a commitment consistency
technique (see Table 1). He also discusses the importance of a socially intimate relationship
between doctors and drug reps in shaping each others practice. In other words, friendly
relationships work well to boost sales (Oldani, 2004).
Expert and peer endorsement
The influence technique of triggering trust in experts is often called the appeal to authority
fallacy by logicians. However philosopher John Locke (1690) used the more insightful term
appeal to modesty. He described this influence technique as a way to gain agreement or silence
opposition by taking advantage of the tendency for people to think it immodest to challenge
statements from an expert.
Reference to expert and peer endorsement are among the five most common ways influence
techniques are used by sales representatives in promotion (see Table 1), (Cialdini, 2000; Roughead,
1998). Trust in an expert rests on the assumption that the expert is competent and unbiased.
When this is justified, it will provide a quick and easy shortcut to obtaining a good answer.
Unfortunately when it is not justified, it can mislead us into incorrect beliefs. Further complicating
this, when people are misled they do not know that their beliefs are unjustified. Documents released during a US court case on promotion of the epilepsy medicine gabapentin (Neurontin)
describe the recruitment of influential physicians in peer-to-peer selling programmes and the
funding of academic physicians identified as thought leaders as part of this promotional campaign (Steinman, 2006). These thought leaders in some cases oversold the medicines potential
benefits for a range of unapproved uses. A presentation by a medical specialist to professional
colleagues does not look like promotion in the same way as a presentation by a company
employee. The success of this influence technique may be due in part to the audiences lack of
awareness that it is part of a product-specific promotional campaign.
As mentioned in Chapter 1, in the US, the number of physician presentations sponsored by
pharmaceutical companies increased from 66,000 in 1999 to 237,000 in 2004, a nearly four-fold
increase over only five years (Caplovitz, 2006). This type of rapid increase in spending on a
specific marketing technique is a good indication that the technique is effective. An internal
Merck analysis made public by the Wall Street Journal suggests that talks by expert physicians
are much more effective in stimulating sales than more traditional marketing techniques such
as sales visits (Hensley, 2005).
A physician who is funded by a company to speak at continuing medical education (CME)
sessions, hospital grand rounds or other educational events may have considerable leeway in
presenting information on the treatment of a specific condition. However, there is usually a
range of opinions amongst experts. A company is more likely to choose an expert who will
recommend its own medicines, particularly profitable new ones. Consequently, whilst some
expert recommendations are justified there is an overall bias towards funding support for experts
who promote more profitable medicines. In most countries, companies are not required to report
the funding they provide to opinion leaders. Five US states have laws requiring such disclosure
and one, Minnesota, publicly discloses physician-specific payments. Physician speakers received
on average US$6,600 in 2003-2004 and the highest payment was US$922,239 (Ross, 2007).
Figure 2 describes the shift in the prescribing of a new intravenous antibiotic that occurred after
physicians at a university hospital attended an all-expenses-paid symposium at a luxury resort,
where the medicine was promoted (Orlowski, 1992). The authors compared prescribing rates
in their hospital before and after the symposium, and also looked at how their hospital compared
with rates at other major hospitals. The physicians who had attended the symposium were asked
whether they believed that attending all-expenses-paid events at luxury resorts would affect their
prescribing; most believed that they would not be influenced.
Figure 2: Effects of "cme" on volume of prescribing
(Source: Orlowski, 1992; see slide from www.nofreelunch.org)
Building relationships
Pharmaceutical companies often select people to become sales representatives who have proven
or potential sales skills and who are attractive. They often receive more ongoing job training
than health professionals. Their training may include advice on how to dress and behave in order
to be more likeable, including video role plays so that they can fine-tune their body language,
what they say, and how they say it. Sales representatives often record detailed information about
health professionals personal preferences and interests. These detailed profiles enable them,
and their colleagues in the same company, to tailor the next encounter around the physicians
profile. They often build up relationships with professionals over many years so that they become
trusted as friends. However, they are not normal friends because they are paid to build up that
relationship. Having spent a long time gaining a professionals trust, a sales representative may
be able to persuade him or her to favour a new medicine in just a few minutes. This is an example
of an influence technique that takes a long time to deliver but triggers a shortcut trusting the
advice of people we like that can lead to a decision very quickly.
The use of gifts
The pharmaceutical industry provides many types of gifts to health professionals, from pens
and meals to sponsored CME, research funding, consultancy fees, speakers honoraria and travel
to exotic locations. In some cases, national regulations and industry self-regulatory codes limit
the types of gifts that may be provided (see Chapter 7 on regulation) but generally gifts of limited
value and educational or research funding are allowed.
What explains the power of even small gifts to shape or manipulate behaviour? Self-interest is
not always the only or even the main factor involved. What the pharmaceutical companies
understand, but health-care professionals often overlook, is that much of social life is based on
reciprocity. The need to return benefit for benefit, kindness for kindness, and favour for favour
is a basic motivator in virtually every human society (Schafer 2004, Sahlins, 1972). As one
researcher wrote, Each of us has been taught to live up to the rule [of reciprocity], and each
of us knows the social sanctions and derision applied to anyone who violates it. Every time
we accept a gift we become beholden to the person who has given it to us. (Cialdini, 2000).
Even token gifts such as coffee mugs can have a surprisingly large effect (Steinman, 2001).
Importantly, trinkets and baubles small gifts of all kinds buy face time and help to establish
a friendly and powerful relationship between the pharmaceutical companies and the health-care
professionals to whom they are attempting to market their products effectively. As Katz (2003)
observes, Those who do not acknowledge the power of small gifts are the ones most likely to
be influenced, because their defenses are down. Contrary to what people expect, small gifts
can be as or more effective in changing attitudes than larger incentives (OKeefe, 2002). Health
professionals who receive valuable and expensive incentives from pharmaceutical manufacturers
may be more aware that the aim is to influence them than if they receive small token gifts of
little value. However, in both cases, health professionals may be influenced through feelings
of reciprocal obligation.
To put this point in another way, whether intended or not, every grant and gift from a pharmaceutical
company to doctors, pharmacists or students comes with strings attached - strings which are
often difficult to recognise but which are nevertheless psychologically influential. Gift-giving
leads to many health professionals feeling an obligation to accept visits from sales representatives
and to be open to what they have to say. Gift pens with a medicines brand name on them are
particularly effective because they constantly remind prescribers of the medicines name so that
it will be more likely to be the first to come to mind when making a decision.
In one US survey, patients were asked the same questions as physicians about the influence of
a variety of gifts (see Figure 3). They were much more likely to see even small gifts such as a
pen or mug as influencing physician prescribing (Gibbons et al., 1998). (For additional information
on gifts from an ethical perspective, see Chapter 6).
Figure 3: Patient and prescriber views on the influence of gifts in a US survey
Percentage that considered gift influential
60
56
48
50
40
30
31
31
29
42
Patients
Physicians
24
20
10
0
8
8
12
Pen
Mug
Lunch
Dinner
Trip
(Source: Gibbons et al., 1998)
Common beliefs about promotion
Despite evidence that promotion is effective, many surveys have shown that health professionals
prefer to think they are not influenced by promotion, as illustrated in Figures 1 and 3. A few
commonly used rationalisations tend not to stand up to closer scrutiny:
# Im too clever to be influenced.
Health professionals often believe that they are not vulnerable to being misled because they are
intelligent and well educated. Intelligence and education do not protect people from being misled
or influenced. Promotion aimed at health professionals takes the skills and education level of
the target audience into account. Intelligence can help a person to see through some promotional
techniques but a person rarely has the time and skills required to see through all of them.
# Im just helping out my patients.
Many health professionals appreciate receiving free samples of new, expensive medicines that
they can in turn provide as a gift to patients. This is seen as especially important in settings
where many patients must pay for their medicines themselves and where patients may be unable
to afford their medicines. Prescribers sometimes say that the only reason they see sales representatives is to receive free samples for their patients. What this ignores is the role of free samples
as a form of market seeding to generate sales, and the evidence that free samples can shift
prescribing choices, in some cases towards less appropriate therapy (Boltri, 2002). Patients do not
pay for their first sample packs, but may end up taking unnecessarily expensive medicines in the
long run.
# I dont take any notice.
Some health professionals believe that they are not adversely influenced by pharmaceutical promotion because they pay it little attention. However, influence techniques can be more effective
if they are not subjected to careful critical attention. Subtle messages that might be rejected if
they were carefully considered instead sneak in under the radar to link the brand or indication
with desires, fears or other emotional responses. This was reflected in a marketing companys
boast to pharmaceutical companies that its advertisements go straight to the hippocampus
(Wolfe, 1996). Even simple repetition has an effect: hearing the same brand name many times
helps it be the first to come to mind when prescribing or dispensing (Mansfield, 2003).
# I see them all so Im not influenced by any.
Another common belief is that exposure to promotion from several companies balances out
competing biases. However this strategy ignores certain biases shared by all competing companies.
For example, pharmaceutical companies promote their most profitable products. Consequently,
expensive new medicines are promoted rather than older generic products regardless of which
is best. Additionally, pharmaceutical companies only have an incentive to promote medicines.
Non-drug treatments and the option not to treat are unlikely to receive equal attention, even
when they are the best option for a specific patient.
From awareness to action
Promotional influences on prescribing and medicine use are a problem because they can lead
to inappropriate treatment choices. This can occur if a medicine is used when it is not needed;
if it is used incorrectly (i.e. for an untested use, at the wrong dose or by the wrong patient); if
it is a poor treatment choice because of its (often unknown) safety and effectiveness profile; or
if it is more expensive than equivalent alternatives. Promotional influences are also a problem
for the profession if they affect public perceptions and result in a loss of trust.
It may be possible to reduce the risk of being misled by learning to recognise influence techniques
and become more wary of promotional activities that use misleading techniques (Shaughnessy
et al., 1994). However, there is evidence from psychological studies that the key to becoming
less vulnerable is initial recognition of ones personal vulnerability (Sagarin et al., 2002).
There are three main strategies for reducing the risk of pharmaceutical promotion leading to
inappropriate prescribing:
# Trying to minimise exposure to promotion;
# Trying to avoid or reduce harm from exposure to promotion;
# Consistent use of techniques that are likely to lead to best practice, including reliance on
more reliable sources of information.
While they are commonsense, none of these strategies has been tested and health professionals
must decide themselves how to respond to the challenge of promotion. Some of the strategies
used to minimise exposure include choosing not to see sales representatives, avoidance of sponsored CME, and refusing gifts and use of medication samples. Other strategies include learning
to recognise use of specific influence techniques. It is also important to be aware of the red
flags that highlight potential conflicts of interest or bias, for example, recognising that speakers
at an educational event are using slides created by the sponsoring pharmaceutical company.
Having a personal plan and identifying and following robust policies concerning potential ethical
conflicts of interest will make it easier to identify and deal proactively with such situations. The
American Medical Student Associations PharmFree pledge is an example of a clear set of
criteria to avoid undue influence (see Box 3). (For a more detailed discussion on conflicts of
interest, see Chapter 6.)
Box 3: American Medical Student Associations PharmFree Pledge
As part of a broader campaign to make US medical students more aware of pharmaceutical
promotion, the AMSA developed a simple pledge for physicians to endorse:
I am committed to the practice of medicine in the best interests of patients and to the
pursuit of an education that is based on the best available evidence, rather than on advertising or promotion.
I, therefore, pledge to accept no money, gifts, or hospitality from the pharmaceutical industry; to seek unbiased sources of information and not rely on information disseminated
by drug companies; and to avoid conflicts of interest in my medical education and practice.
(AMSA, 2001).
The foundations for good clinical practice include development of skills in rational prescribing
and dispensing, including the use of practical, evidence-based, decision-making techniques that
are aligned with such skills. Examples of these might be the development of a personal formulary
and patient-oriented treatment goals. The WHO manual Guide to Good Prescribing provides a
practical framework for the development of prescribing skills (available at: http://whqlibdoc.who.int/
hq/1994/ WHO_DAP_94.11.pdf). There are also other good resources available on improving
prescribing appropriateness. (Chapter 8 gives further information on how to critically appraise
research evidence and find sources of independent information.)
Conclusion
One of the greatest ethical challenges facing health professionals is the influence of pharmaceutical
promotion on professional practice. Interactions between the pharmaceutical industry and health
professionals are complex. Strategies involving a combined approach are therefore likely to be
needed to be aware of ones own vulnerability to influences, avoidance of conflicts of interest
and unnecessary exposure, awareness and transparency when exposure and conflicts of interest
are unavoidable and development of positive strategies to improve prescribing and dispensing.
Whatever the strategy, the key goal is to ensure that good patient care comes first.
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Chapter 3 - Analysing pharmaceutical advertisements in medical journals | 41
Chapter 3
Analysing pharmaceutical
advertisements in
medical journals
Joel Lexchin
Although the pervasive presence of pharmaceutical advertisements in medical journals may
suggest otherwise, companies only spend a small fraction of each promotional dollar on advertisements. US figures from 2005 show that medical journal advertising cost companies US$499
million out of a total promotional budget of US$27.7 billion (IMS, 2005). Journal advertising
is used with visits from sales representatives and detailing aids (material left behind by sales
representatives) to deliver and reinforce a message about a medicine. According to an executive
from the research organisation that has undertaken the most extensive media research on the
prescription medicine industry: Advertising magnifies the detailing effort at a fraction of
detailing expense. In effect, detailing provides the power in the marketing effort and advertising
provides the efficiencies. (Liebman, 2000). For every dollar spent on medical journal advertisements
during the first four years that a medicine is on the market, the return on investment (ROI) is
US$2.43; after this time, ROI increases to over US$4.00 (Liebman, 2000).
Not only are journal advertisements successful in increasing sales, and therefore prescriptions,
but there is also some evidence that physicians who use journal advertisements as an information
source prescribe less appropriately (Bower, 1987; Ferry, 1985).
Journal advertisements attract attention because they are visually appealing. Professionals may
also see them as a way of keeping up-to-date. Since advertisements can affect prescribing, it is
important to be able to critically evaluate their contents and to compare the information provided
with that obtained from unbiased information sources.
By the end of the session based on this chapter, you should:
# Know what kinds of information the WHO Ethical Criteria for Medicinal Drug Promotion
recommend for inclusion in journal advertisements;
# Be familiar with the different components of journal advertisements;
# Understand the ways in which each of the components can be used to convey messages;
# Be able to evaluate each of the different components according to the criteria set out in this chapter.
What information should be in a journal advertisement?
The Ethical Criteria for Medicinal Drug Promotion developed by the World Health Organization
(WHO) suggest the types of information that, as a minimum, should be contained in a journal
advertisement (WHO, 1988), (see Box 1). The aim is to ensure that basic information needed
for prescribing decisions is present. The medicines international nonproprietary name (INN),
usually the generic name, is a key piece of information that should always be included. Generic
names help doctors and pharmacists identify which class a medicine belongs to and can prevent
doctors from unknowingly prescribing two medicines from the same class to a patient.
Box 1: Recommended information in journal advertisements
The World Health Organizations Ethical Criteria recommend that the following information be included in pharmaceutical advertisements appearing in medical journals.
# Name(s) of the active ingredient(s) using either international nonproprietary name
(INN) or the approved generic name of the medicine;
# Brand name;
# Content of active ingredient(s) per dosage form or regimen;
# Name of other ingredients known to cause problems;
# Approved therapeutic uses;
# Dosage form or regimen;
# Side effects and major adverse medicine reactions;
# Precautions, contraindications and warnings;
# Major interactions;
# Name and address of manufacturer or distributor;
# Reference to scientific literature as appropriate.
(WHO, 1988)
While advertisements from developed countries typically contain nearly all of the information
listed in the box, this is not always the case in developing countries. Table 1 from a 1993 study
presents the results of a survey comparing advertisements in developed and developing countries.
It is obvious from examining this table that safety information is systematically ignored in
advertisements from developing countries. More recent work analysing advertisements in India
(Lal, 1997; Lal, 1998), Brazil (Mastroianni, 2005) and the Russian Federation (Vlassov, 2001)
shows that they continue to leave out essential information recommended by WHO.
Table 1: Information in advertisements in developed and developing countries
Type of information
Percentage of advertisements containing information
Developed countries*
Developing countries**
Indications
89
87
Contraindications
61
28
Warnings
55
29
Side effects
64
29
(Herxheimer, 1993)
*
Denmark, Finland, France, Ireland, Italy, Norway, Spain, Sweden, Switzerland and United Kingdom
**
Brazil, Indonesia, Nepal, Pakistan, Sri Lanka, Turkey, United Republic of Tanzania and Zimbabwe
Just because each of the categories of information is present in an advertisement does not necessarily mean that the advertisement will give a complete picture of the medicines safety and
effectiveness and how to prescribe the medicine appropriately. Although advertisements in
Australian journals improved during the 1980s and early 1990s, by 1992, 4% still contained
unacceptable graphics, 7% had unacceptable claims and 15% had unacceptable references
(Carandang, 1994). In 1992, the Annals of Internal Medicine published an article that critically
examined the scientific accuracy of over 100 pharmaceutical advertisements in 10 leading
medical journals (Wilkes, 1992). Overall, physician and pharmacist reviewers judged that 34%
should have had major revisions before being published and 28% should not have been published
at all. In 1995, most Irish doctors expressed strong reservations about the quality of advertisements
in Irish medical journals, with 90% believing that the advertisements were of poor educational
value (Hemeryck, 1995).
Figure 1: What information should a medicine advertisement contain?
(Advertisement from the Indian Journal of Dermatology, Venereology, Leprology. Vol 71, Issue 6, Nov-Dec 2005.)
The main components of advertisements
This chapter will consider four main elements of journal advertisements: graphs and data; text;
references; and pictures and images.
Graphs and data
Graphs and data are often used in advertisements to provide a scientific justification for the claims
that are being made about a medicine. A graph can provide a clear, visually striking summary of
study results. However, an analysis of 74 graphs that appeared in 64 advertisements in leading US
medical journals found that 8% had errors, 5% were visually confusing and 12% used non-standard
graphing techniques. Only 36% of graphs were self-explanatory and there were many more visual
distractions and numeric distortions than in graphs found in medical journal articles (Cooper, 2001).
Figure 2 presents an example of a graph on a promotional website with one type of numeric
distortion (for details, see caption below figure). There are many other types of examples,
including not starting a scale at zero, making a very small difference in outcomes look large,
highlighting one small part of a studys results and so on.
Figure 2: What is numeric distortion? An example
Deaths as a result of
cardiovascular disease
10,000
Men
Women
1,000
100
10
35-39
45-49
55-59
70-74
+85
Age (years)
(Source: Bayer, Schering Pharma, 2009)
This graph appeared on a website on menopause by Schering, which markets post-menopausal hormone
treatments: http://www.menopause-infoline.com/scripts/en/consumer/index. and http://www.menopauseinfoline.com/scripts/en/consumer/01/c_01_04_02.php. The graph accompanies text that stresses the
increase in heart disease risk faced by women as they age.
The y-axis, on the left, is a logarithmic scale, an unusual scale to use on such a graph. Readers glancing
at the graph might assume the scale was arithmetical, with equal numbers between the horizontal lines.
For example, if one glances at the bars for ages 70-74, it looks like nearly as many women as men are
represented. In fact, the bar represents 1,000 deaths among women versus 2,000 among men.
Data on medicine benefits and harmful effects
Closely related to the issue of the quality of graphs is whether advertisements convey information
as a relative risk reduction (RRR), absolute risk reduction (ARR) or number needed to treat (NNT).
A relative risk reduction is the percentage reduction in the risk of targeted complications
between two groups. A drop in mortality from 2% to 1% would be a RRR of 50%, because 1%,
or 1 in 100 people, is half as many as 2%, or 2 in 100 people. An absolute risk reduction is
the absolute percentage difference in the risk of targeted complications between two groups. A
drop in mortality from 2% to 1% would be an ARR of 1%. The number needed to treat is the
number of patients who have to be treated in order to provide the desired effect from the medicine
in one person. A drop in mortality from 2% to 1% would be a NNT of 100 (ARR=1; NNT=
100/ARR). In other words, for every death prevented, 100 people would need to be treated.
There is evidence that physicians enthusiasm for a treatment varies depending on how the results
are presented. Specifically, the inclination to use a particular medicine therapy is greatest when
results are given as a RRR and lowest when they are given as a NNT (Cranney, 1996; Naylor,
1992). A 50% relative reduction looks much more impressive than a 1% absolute reduction.
Often the word relative is not stated, adding to the confusion. (Chapter 8 describes these
outcome measures in greater detail.)
Figure 3: Misleading use of relative risk reductions
(Advertisement brochure from Alonso, 2007.)
This advertisement for raloxifene (Evista) is an illustration of a brochure distributed by sales representatives
to family physicians in Spain. Raloxifene is approved in Spain to prevent fragility fractures in women with
osteoporosis. The advertisement was judged by regional medicine authorities in Madrid to be illegal
because it promotes an unapproved use. The lower box with the large 75% is promoting use in women
without a diagnosis of osteoporosis (75% reduction in vertebral fractures in women with osteopaenia)
(Alonso, 2007).
Impressive risk reductions, but what do they really mean?
47% relative risk reduction in radiological vertebral fractures
# A radiological vertebral fracture is not a broken bone in the traditional sense as the
woman has no symptoms. It is a loss in vertebral height seen on x-ray. The cut-off for
the amount of loss in height considered to be a fracture is arbitrary, and is 15% in
some studies, 20% in others, including this study.
# What is the absolute risk reduction? Over 3 years, 6% of women on raloxifene had
radiological vertebral fractures versus 10% on placebo, a 4% difference.
# Numbers needed to treat: 25 women must be treated for 3 years to prevent one
radiological vertebral fracture. However, only a difference on x-ray would be prevented,
not pain or disability.
75% relative risk reduction in symptomatic vertebral fractures
# These x-ray changes led to back pain and were therefore clinically meaningful.
# In total, less than 1% of women had clinical vertebral fractures in 3 years. No breakdown
is provided of numbers on raloxifene versus numbers on placebo.
# The published report does not allow ARR to be calculated a guess from the relative
risk reduction figures and total number of women is around 0.7%.
# In the same cited study, 1% of women on raloxifene developed venous thromboembolism
(deep vein thrombosis or pulmonary embolism) compared to 0.03% on placebo;
absolute risk increase = 0.7% (Ettinger, 1999).
A Canadian study that looked at 22 journal advertisements found that half of the time, in 11 of
these advertisements, results were reported only as a RRR. The other 11 provided enough
information to calculate ARR and NNT, however, they did not state these values directly (Lexchin,
1999). Australian advertisements that made claims explicitly reporting quantitative outcomes
also did not report data as either the ARR or NNT (Loke, 2002).
Advertising copy cannot contain all the methodological and statistical detail found in the original
reports but it should allow readers to know if the research being cited meets the basic criteria
for validity, significance of results and applicability to the readers practice (Rothermich, 1996).
Gutknecht analysed 43 data presentations in 33 advertisements that contained quantitative
research results. References to randomisation and blinding were found in less than one-half of
the 43 data presentations. P values (the probability that a specific result occurred by chance)
were frequently provided, but confidence intervals and references to power and NNT were not
provided in any of the advertisements (Gutknecht, 2001). Similarly, a study of Finnish advertisements found that these adverts failed to mention confidence intervals or NNT (Lankinen, 2004).
Box 2: How to evaluate data and graphs presented in pharmaceutical advertisements
# Is information presented as either absolute risk reductions (ARR) or number needed
to treat (NNT)?
# Does the advert indicate if a study was randomised and blinded?
# When statistical significance is given are confidence intervals and power calculations
included?
# Are graphs simple to read and do they have appropriately labelled axes?
# Are graphs obscured by other visual material?
# Are the titles of graphs clear and do they explicitly say what the graph is about?
# If the graph comes from an article or another source is it reproduced exactly as it
appeared in the original source?
# Are data in graphs presented in such a way as to make it easy to determine whether
or not any differences are clinically meaningful?
Advertising text
# Claims made in advertisements
One of the essential features of a journal advertisement is the product claims. These claims can
take many forms. They may be about effectiveness, safety, enhancement of quality of life, or
sometimes costs or convenience. Sometimes a precise claim is made about a measurable treatment
outcome; other times claims are much more vague.
The claims made in a sample of 245 advertisements from four major Finnish medical journals
published in 2002 were examined (Lankinen, 2004). These claims were classified into four
groups: unambiguous clinical outcome, vague clinical outcome, emotive or immeasurable
outcome and non-clinical outcome. Out of 883 claims only 337 (38%) were referenced. Nine
percent of the claims implied unambiguous clinical outcomes, 68% included vague or emotive
statements. Twenty-one percent of the references were irrelevant to the claim. There was a fair
amount of non-scientific and scientific support for the 73 unambiguous claims, but not a single
claim was supported by strong scientific evidence (meta-analysis or multiple high-quality studies).
Vague, emotive and non-clinical claims were significantly more often supported by irrelevant
references than unambiguous claims.
Advertisements from medical journals in other countries are little different from those in Finland
with respect to whether or not they contain supporting information. Only 45% of 855 claims
in Australian advertisements were supported by compelling evidence (randomised, controlled
trials or better) (Loke, 2002). A review of Spanish advertisements found that 44% of claims for
which a reference was cited were not supported by the referenced studies. Usually this was
because the advertisement recommended the product for a patient group that was not included
in the study (Villanueva, 2003).
# Quality of life claims
Quality of life claims may reflect one or more of three dimensions: physiologic, functional
(physical, social and psychological functioning) and overall well-being. Advertisements most
often claim that the product improves quality of life in either the physiological or physical
functioning dimensions. In a US review of these claims (Rothermich, 1996), 11 out of 26
advertisements (42%) making claims about quality of life were non-compliant with US Food
and Drug Administration regulations, mainly because of biased information presentation, with
too much prominence given to medicine benefits as compared to harmful effects.
# Claims about costs and economic benefits
Doctors often do not know the relative costs of the medicines they prescribe, but they may try to
prescribe lower-cost medications to low-income patients and those without medicine insurance
(Ryan, 1990; Safavi, 1992). Therefore, it is not surprising that economic messages in advertisements
typically claim that a medicine is less expensive than alternatives. One study of such advertisements
found that simple cost differences were usually supported by evidence, but most claims of costeffectiveness or of positive effects of the treatment on patients productivity were not supported
by evidence (Neumann, 2002). Inaccurate or deceptive information about economic benefits could
lead to doctors prescribing more expensive medicines that do not offer any clinical advantages.
# Efficacy and safety claims
Claims about clinical outcomes are important since this is the key aim of pharmacotherapy.
Table 2 summarises the types of claims in Australian and Finnish advertisements and shows that
in both countries only a minority of the claims are about unambiguous clinical outcomes (Loke,
2002; Lankinen, 2004). A significant proportion is emotive, for example, one of a kind or a
source of healing power, and almost a quarter are for non-clinical outcomes which are usually
about surrogate markers, such as changes in laboratory measures or physiological measurements,
rather than meaningful clinical changes in morbidity events or mortality. Surrogate end points
may or may not correlate with outcomes that are important to patients.
Whatever the nature of a claim, it should be presented clearly, should be based on methodologically
strong research and should accurately reflect cited references. Ideally, claims should also reflect
treatment outcomes of importance to patients health and lives.
Table 2: Types of claims in pharmaceutical advertisements
Unambiguous
clinical
outcome
Vague
clinical
outcome
Emotive or
immeasurable
outcome
Non-clinical
outcome
Total
number
of claims
No.
%
No.
%
No.
%
No.
%
Australia
418
28
437
29
301
20
346
23
1,504
Finland
81
9
326
37
270
31
206
23
883
(Source: Loke, 2002; Lankinen, 2004)
References in advertisements
Advertisements should include references whenever a claim is made that reflect scientific evidence. The claim must be consistent with cited research and the research should be designed
with adequate methodology. For example, effectiveness claims should generally be based on
evidence from double-blind, randomised, controlled trials. It is also important for health professionals to be able to retrieve cited references, so that they can independently evaluate them.
Otherwise, any limitations or inconsistencies between the evidence and the claims will remain
hidden.
These are a few common problems with referencing in advertisements:
# No references are provided for claimed treatment effects;
# Reference is to company data on file, which is not publicly available and has not been
independently reviewed;
# A poster presentation is cited; generally inadequate information is provided on methods in
poster presentations to judge reported results;
# Review articles that selectively present results are cited, not original research;
# The referenced article is in a journal supplement sponsored by the manufacturer;
# Study results in the cited reference are inconsistent with the advertising claim;
# The study is of poor methodological quality, raising questions about the validity of the results.
For example, Lexchin and Holbrook requested all references for a set of published advertisements,
87 in total, from the manufacturers (Lexchin, 1994). Ten of these references were to unpublished
data on file. They eventually received 90% of the requested references; 4 of the 10 data on
file were not sent. Although 76% of the references supported cited claims, the overall methodological quality of the references was judged to be unacceptably low (Lexchin, 1994).
In a similar study, Villanueva and colleagues (2003) retrieved 82% (102 out of 125) of references
cited in advertisements. However, almost half of the references that were not found were to
data on file. Over three-quarters of the references came from journals with a high impact
factor (a measure of how often articles in a journal are cited) and 82% of the 102 were from
randomised clinical trials.
In another analysis of references in advertisements, Cooper and Schriger (2005) only received
37 replies to 88 requests for cited data on file, 19 of which were refusals; only 18 (20%) were
provided. Out of 294 references citing original research, 58% were sponsored by or had authors
affiliated with the products manufacturer. When pharmaceutical companies sponsor research
on their products, the results are four to five times more likely to be favourable to the product
than when financing is from other sources (Als-Nielsen, 2003; Lexchin, 2003). Finally, in
developing countries it may not be possible to retrieve references because the information in
citations is incomplete. This was the case 90% of the time in one study in India (Lal, 1996).
Box 3: How to evaluate references in pharmaceutical advertisements
# Do citations contain all of the information necessary to identify references?
# Are all references cited retrievable including those to data on file?
# Are references of high methodological quality?
# Do journal references come from peer-reviewed medical or pharmacy journals?
# Did the company finance the research reported in the reference?
# Claims in antibiotic advertisements
Advertisements for antibiotics raise specific concerns, as overuse of antibiotics can lead to
resistance and diminish the usefulness of these medicines. Many advertisements for antibiotics
do not mention resistance (Gilad, 2005). In some cases, as in the advertisement shown in Figure
4, advertisements fail to state that a common infection usually resolves without antibiotics or
that it is often wiser to reserve newer broad-spectrum antibiotics for second-line use, when older
narrower-spectrum products fail, in order to avoid unnecessary development of resistance.
Figure 4: Antibiotic advertising
(Advertisement from the Canadian Medical Association Journal, 13 September 2005.)
This advertisement for clarithromycin (Biaxin) suggests putting the medicine at the top of your list to
treat children. Many common childhood infections do not require antibiotics.
Box 4: How to evaluate the text in pharmaceutical advertisements
# Are generic names used as frequently as brand names and is the type the same size
as that used for the brand name?
# Are claims in advertisements restricted to unambiguous clinical outcomes or meaningful
economic claims?
# If there are claims about surrogate endpoints is there also information that directly
links changes in these end points to meaningful clinical outcomes?
# Are all claims for safety, effectiveness and cost-effectiveness in advertisements backed
up by high-quality evidence (evidence from meta-analyses or randomised, controlled trials)?
# If there are claims for use of a medicine in a particular population are they based on
high-quality evidence that comes from medicine use in that population?
# Is information about safety given the same prominence and placement as information
about effectiveness?
# Do economic claims give actual prices of different alternatives? Are there vague claims
about costs, such as costs less?
# Do advertisements for antibiotics recommend use that is consistent with guidelines to
prevent unnecessary development of resistance?
Pictures and images in advertisements
Pictures and images in journal advertisements can help shape the way that doctors view patients.
Some common portrayals are: as helpless victims of disease, as partners in developing therapeutic
options, as people who are demanding, as being intelligent or emotional. The images in advertising
can also sway how physicians and pharmacists view themselves, for example, as caring professionals able to solve a patients problem.
These pictures can either reinforce or challenge generally held societal prejudices about different
groups of people. Pictures and images can also serve as metaphors as advertisers seek to identify
their products with a particular image, e.g., a maker of an antidepressant may hope to identify
its medicine with images of brightness as a symbol of recovery. The use of metaphors tends to
reduce illness to a single dimension and treatment to a single modality (medicines) thereby taking illness out of its social context and simultaneously denying a role for any other form of therapy.
# Reinforcement of social stereotypes
Much of the analysis of the way different groups are portrayed in advertising has focused on
women. A random sample of US general and specialty medical journals found that men were
usually depicted as doctors and women as patients taking medicines. In general, men were more
often portrayed as workers and when women were shown working, it was usually in stereotypically
feminine jobs such as secretaries and waitresses (Hawkins, 1993).
An analysis of advertisements for antidepressants in Scandinavian and US journals in 1995
showed that the Scandinavian advertisements tended to construct antidepressants as female
gendered and depression as detached from any social context. Both US and Swedish advertisements
used images of couples and showed the medicine as being key to maintaining the relationship,
and the woman as the person needing the medicine (Lovdahl, 1999).
Figure 5: Images of women in antidepressant advertising
(Advertisement from the American Journal of Psychiatry 2006;163(9)).
The image in this advertisement suggests a number of things about depression, women and pharmaceutical
treatments.
Although depression is diagnosed about twice as often in women than in men the ratio of females
to males in advertisements in the American Journal of Psychiatry was 5:1 and in American
Family Physician it was 10:0. The authors of this study speculated that the overrepresentation
of women may reinforce cultural stereotypes and result in diagnosis and treatment of women
in gender-biased ways (Hansen, 1995). Another analysis noted that women were under-represented
in advertisements for cardiovascular medications and that this could contribute to under-diagnosis
of cardiovascular disease in women, together with factors such as differences in symptoms and
expression of disease (Ahmed, 2004; Leppard, 1993).
There are also biases in the way that the elderly are presented in journal advertisements. In a
sample of advertisements from Canadian medical journals, Lexchin (1990) found that the special
needs of the elderly often did not appear to be taken into account and this could contribute to
misprescribing to the elderly. Finally, in multicultural societies, advertisements have a preponderance
of whites both as health-care providers and as patients (Hawkins, 1993; Munce, 2004).
# Appeals to myth
The use of images to construct mythical and potentially misleading associations between disease
and medicine was evaluated in 26 advertisements appearing in issues of the British Medical
Journal between 1999-2001 (Scott, 2004). This analysis suggests that myth is often deployed
in drug advertising to depict exaggerated therapeutic efficacy: armed with such drugs, the
clinician can liberate patients from the oppression of disease and restore them to normality.
With medicine as their alibi advertisers exploit the nude. Mythology transports the clinician
into a wider sociocultural context than that of medicine alone. Viewing exotic or erotic scenes
derived from old masters, the reader is relocated from office to gallery, obtaining visual relief
from the clinical grind. Associations between diseases and drugs are made to seem natural,
unmotivated by commercial interest.
Ferner and Scott (1994) note that symbols in advertisements have complex and multiple meanings
and are able to evoke strong feelings. Doctors may be unaware of the hidden messages in images
or may be reluctant to acknowledge them and this reluctance may leave them vulnerable to
misprescribing.
Psychotropic medicine advertisements are particularly prone to using symbols or metaphors to
convey hidden meanings. Kleinman and Cohen (1991) showed how images in advertisements
distort debate over treatment options and legitimise existing social relations and attitudes. The
majority of advertisements in the British Journal of Psychiatry and its Irish counterpart used
metaphors as their main marketing strategy instead of providing adequate information necessary
for appropriate prescribing (Quinn, 1997). Finally, an analysis of eight advertisements for
antidepressants appearing in issues of the Canadian Journal of Psychiatry between 1989 and
2002 showed how existing paradigms of social worth can be used by the drug industry to create
perceptions of their products, with the intention of promoting sales. (Peppin, 2003).
Box 5: How to evaluate pictures and images in pharmaceutical advertisements
# Do the people portrayed in the advertisements reflect the racial and ethnic composition
of people in your country?
# Are both men and women portrayed in advertisements as both patients and healthcare providers in equal numbers?
# Are the ways that men and women are portrayed (as workers, facial expressions, body
language, etc.) similar?
# How are the elderly portrayed in advertisements?
# Are symbols or metaphors used in advertisements?
# What kinds of associations do these symbols and metaphors convey?
# Are illnesses portrayed as individual events or are they put into a social context?
Conclusion
As a minimum, advertisements for prescription medicines should contain the key information
listed in the WHO Ethical Criteria concerning the medicine name and manufacturer, who it is
indicated for, key beneficial and harmful effects and reference to scientific evidence to back
treatment claims. This provides basic knowledge of a medicines characteristics required for
prescribing decisions. However, the presence of this information does not ensure that the advertisement promotes appropriate use. To critically appraise advertisements, it is important to
systematically look at all of the advertisements elements: data and graphs, text, references and
images. Often social as well as medical dimensions come in, such as the portrayal of the relationship between doctors and patients, or the way women or the elderly are portrayed. Additionally,
myth and emotive imagery may be used to create an impression of a brand that has little to do
with evidence of the products effects and characteristics. Underlying any critical appraisal of
advertising, the key question is what the messages and images in the advertisement mean for
patient health.
Student exercises
1. Advertising analysis
# Look at the advertisement shown in Figure 1 in this chapter. Compare the information
provided to the types of information that should be present, according to the WHO
Ethical Criteria (Box 1). What information is missing? Next to each type of missing
information, explain whether you think it is needed and why or why not.
# Pick three or four advertisements from current issues of the major medical or pharmacy
journal(s) in your country and examine and compare them to reliable and unbiased
sources of information about the medicine to determine if they contain the information
recommended in the WHO Ethical Criteria. (See Chapter 8 for more details on sources
of reliable and unbiased information.)
# Find a local advertisement that includes at least one graph. Use the criteria given in
Box 2 in this chapter to evaluate the content.
# Collect the advertisements in the latest issue of your national medical or pharmacy
journal. How many advertisements include references? How many are to data on file,
to poster presentations, or to review articles? How many citations are incomplete? How
often did companies sponsor the studies? Try to retrieve all of the references from one
advertisement. Did you succeed? Why or why not? Using the section in Chapter 8 on
critical appraisal, comment on the strength of methodology and relevance to claims for
which they were cited.
# Analyse the different components of the advertisements (graphs and data presentation,
text, references and pictures/images) according to the criteria outlined in this chapter.
# See the list of independent information sources in Chapter 8. Try to find a reference
covering at least one of the medicines for which you have an advertisement. How does
this information compare with the messages in the advertisement?
# Choose a convenience sample of health-care professionals, such as your professors,
friends or colleagues. Show the current advertisements to them and ask them their
opinions of the advertisements. Do their opinions match your analysis? What differences
are there and how do you think those differences would affect prescribing?
2. Create your own spoof advertisement
# Choose a medicine that is currently being heavily advertised and for which you also
have a source of independent information (see Chapter 8 for references).
# Pick a recent advertisement for the medicine.
# Go through the advertisement and pick out any implied or stated messages in images,
text or graphs and data that are inconsistent with the independent information.
# Look as well for any social messages or use of myths in the advertisement.
# Create your own spoof advertisement for this medicine using similar messages. This
can be in any form: a journal advertisement, a poster, a promotional patient brochure,
a song to play on radio, a short play, a video and so on.
3. Debate the role of advertising in medical journals
# Some critics of pharmaceutical advertising say that health professional journals should
not accept any advertisements from pharmaceutical or medical device companies.
(See: Fugh-Berman A, Alladin K, Chow J (2006). PLoS Medicine 3 (6):e130.
(See: http://medicine.plosjournals.org/ perlserv/?request=get-document&doi=
10.1371/journal.pmed.0030130).
# Others cite freedom of expression and say that pharmaceutical companies should be
able to advertise as long as the advertisements are not deceptive.
# Divide into teams and debate the pros and cons of health professional journal policies
banning pharmaceutical advertising entirely versus continuing to run the advertisements
but regulating them more strictly.
4. Types of advertising claims
# Collect 6 advertisements from a medical or pharmacy journal.
# Make a list of all the claims in the text and headlines for each of the advertisements.
# How many of them fit into each category listed in Table 2?
References
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Chapter 4 - Pharmaceutical sales representatives | 61
Chapter 4
Pharmaceutical sales
representatives
Andy Gray, Jerome Hoffman and Peter R Mansfield
The presence of pharmaceutical industry sales representatives almost seems a fact of life at
many modern medical centres and universities around the world. Many medical and pharmacy
students come into contact with pharmaceutical industry sales representatives during their
training. Later on in the careers of many health professionals, encounters with sales representatives
can occur on a daily basis, taking up a substantial portion of a busy health professionals time.
However, health professionals have a choice in the matter - they may choose not to see pharmaceutical sales representatives at all or they may attempt to manage such interactions.
This chapter aims to provide information to help you make up your own mind on this issue.
This choice has important consequences for health professionals practice and patients, so
requires careful consideration.
By the end of the session based on this chapter, you should be able to answer a series of questions
on your interactions with sales representatives:
# In what ways, if any, might I hope to benefit from meeting with sales representatives?
# How are sales representatives selected, trained, supported and managed?
# What information do sales representatives provide?
# How might contact with sales representatives influence me in a positive or negative way?
# Should I have contact with sales representatives at all?
# Is it possible, if I choose to have contact with sales representatives, to minimise the potential
harm and maximise the potential benefit for my professional development and practice?
This chapter presents evidence that we believe can be helpful in addressing these questions, and
ends with a series of activities that will allow students to work on the issue in more depth.
The current situation
Many medical and pharmacy students come into contact with pharmaceutical sales representatives
during their training. Sales representatives may be invited to address students in a formal setting
or may exhibit their products at various functions. They may provide food and drink or sponsorship
for educational sessions.
In general, most of sales representatives time is directed at one-to-one contact with practising health
professionals. Spending on this form of promotion also called detailing represents a large
proportion of the pharmaceutical industrys marketing budget. In 2004, in the US, it was estimated
that there were 90,000 sales representatives and that pharmaceutical manufacturers spent more than
US$10 billion on this form of marketing (Lam, 2004). This may represent more than a quarter of
their total marketing expenditure and represent at least US$8,000 to US$13,000 spent on such activities
per year, for each physician in the US. Sales representatives are also involved in the provi

Understanding and responding to

Transcription

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